FDA Adverse Event
Injury
Summary report: N
BIOHORIZONS
MDR report key: 23586279
·
Received November 18, 2025
Report
- Report Number
- 1060818-2025-36100
- Event Type
- Injury
- Date Received
- November 18, 2025
- Date of Event
- August 7, 2025
- Report Date
- November 19, 2025
- Manufacturer
- BIOHORIZONS
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
RECORD CANCELED IN ERROR PRODUCT WAS MISTAKEN AS A NON DZE PART.
Description of Event or Problem · 0
IMPLANT FAILED TO OSSEOINTEGRATE.
Description of Event or Problem · 0
IMPLANT FAILED TO OSSEOINTEGRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1494890 | BIOHORIZONS | DENTAL IMPLANT | DZE | BIOHORIZONS | 3015OS2 | 0803152 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |